Status:

COMPLETED

Gemcitabine Plus Bevacizumab in Locally Recurrent or Metastatic Breast Cancer

Lead Sponsor:

Eli Lilly and Company

Collaborating Sponsors:

Genentech, Inc.

Conditions:

Metastatic Breast Cancer

Locally Advanced Breast Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

Brief Summary

To determine how long Gemcitabine and Bevacizumab will stop the cancer from growing in patients with advanced breast cancer.

Eligibility Criteria

Inclusion

  • Must be female and greater than or equal to 18 yrs of age
  • Participants must have confirmed cancer with measurable or evaluable, locally recurrent or metastatic disease.
  • Participants must have received a taxane as neo-adjuvant and/or adjuvant therapy
  • Participants may have received prior hormone therapy for locally recurrent or metastatic disease

Exclusion

  • Participants with breast cancer overexpressing Human Epidermal growth factor Receptor 2 (HER2) gene amplification
  • Prior chemotherapy or targeted therapy for metastatic breast cancer
  • Prior treatment with gemcitabine, trastuzumab, lapatinib or bevacizumab in any setting
  • History of, or active brain mets
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to treatment, or anticipation of need for major surgical procedure during course of study
  • Prior history of high blood pressure crisis
  • Have a serious, nonhealing wound, ulcer, or bone fracture

Key Trial Info

Start Date :

March 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2011

Estimated Enrollment :

52 Patients enrolled

Trial Details

Trial ID

NCT00623233

Start Date

March 1 2008

End Date

January 1 2011

Last Update

January 9 2012

Active Locations (16)

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Page 1 of 4 (16 locations)

1

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Fayetteville, Arkansas, United States, 72703

2

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Fresno, California, United States, 93720

3

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

San Diego, California, United States, 92121

4

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Longmont, Colorado, United States, 80501